Methods and devices for preparing and implanting tissue scaffolds

ABSTRACT

Methods and devices are provided for preparing and implanting tissue scaffolds. Various embodiments of scribing tools are provided that are configured to mark one or more predetermined shapes around a defect site in tissue. The shape or shapes marked in tissue can be used to cut a tissue scaffold having a shape that matches the shape or shapes marked in tissue. In one embodiment, the scribing tool used to mark a shape in tissue can also be used to cut the tissue scaffold.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/243,363, filed on Aug. 22, 2016 (now U.S. Pat. No. 10,449,052), andentitled “Methods and Devices For Preparing and Implanting TissueScaffolds,” which is continuation of U.S. patent application Ser. No.13/788,853, filed on Mar. 7, 2013 (now U.S. Pat. No. 9,421,082), andentitled “Methods and Devices for Preparing and Implanting TissueScaffolds,” which is a continuation of U.S. patent application Ser. No.13/653,867, filed on Oct. 17, 2012 (now U.S. Pat. No. 8,469,980), andentitled “Methods and Devices for Preparing and Implanting TissueScaffolds,” which is a divisional of U.S. patent application Ser. No.12/412,492, filed on Mar. 27, 2009 (now U.S. Pat. No. 8,308,814), andentitled “Methods and Devices for Preparing and Implanting TissueScaffolds” which are hereby incorporated by reference in theirentireties.

FIELD OF THE INVENTION

The present invention relates to methods and devices for preparing andimplanting tissue scaffolds.

BACKGROUND OF THE INVENTION

Injuries to soft tissue, such as cartilage, skin, muscle, bone, tendon,and ligament, frequently require surgical intervention to repair thedamage and facilitate healing. Such surgical repairs can includesuturing or otherwise repairing the damaged tissue with known medicaldevices, augmenting the damaged tissue with other tissue, using animplant, a graft, or any combination of these techniques.

One common tissue injury involves damage to cartilage, which is anon-vascular, resilient, flexible connective tissue. Cartilage typicallyacts as a “shock-absorber” at articulating joints, but some types ofcartilage provide support to tubular structures, such as for example,the larynx, air passages, and the ears. In general, cartilage tissue iscomprised of cartilage cells, known as chondrocytes, located in anextracellular matrix, which contains collagen, a structural scaffold,and aggrecan, a space-filling proteoglycan. Several types of cartilagecan be found in the body, including hyaline cartilage, fibrocartilage,and elastic cartilage. Hyaline cartilage can appear in the body asdistinct pieces, or alternatively, this type of cartilage can be foundfused to the articular ends of bones. Hyaline cartilage is generallyfound in the body as articular cartilage, costal cartilage, andtemporary cartilage (i.e., cartilage that is ultimately converted tobone through the process of ossification). Fibrocartilage is atransitional tissue that is typically located between tendon and bone,bone and bone, and/or hyaline cartilage and hyaline cartilage. Elasticcartilage, which contains elastic fibers distributed throughout theextracellular matrix, is typically found in the epiglottis, the ears,and the nose.

One common example of hyaline cartilage injury is a focal articularcartilage defect in the knee. A strong impact to the joint can result inthe partial removal of a cartilage fragment of various size and shape orsufficiently damage the extracellular matrix of the cartilage to causedegeneration of cartilage. If left untreated, damaged articularcartilage can restrict joint function, cause debilitating pain and mayresult in long term chronic diseases such as osteoarthritis, a diseasecharacterized by cartilage breakdown and unfavorable changes in theunderlying bone. As injuries to the articular cartilage tissue generallydo not heal on their own, surgical intervention is often necessary torepair symptomatic lesions. The current modality of treatment consistsof lavage, removal of partially or completely unattached tissuefragments. In addition, the surgeon will often use a variety of methodssuch as abrasion, drilling, or microfractures, to induce bleeding intothe cartilage defect and formation of a clot. It is believed that thecells coming from the marrow will form a scar-like tissue that isfibrocartilaginous in nature and can only provide temporary relief tosome symptoms. Unfortunately, the repair tissue does not have the samemechanical properties as hyaline cartilage and therefore degrades fasterover time as a consequence of wear. Patients typically require asecondary procedure to alleviate symptoms.

More recently, experimental approaches involving the implantation ofautologous chondrocytes have been used with increasing frequency. Thechondrocytes are obtained by harvesting a piece of cartilage from apatient using a biopsy and then cells are extracted from the tissuesample and cultured to the appropriate numbers in the laboratory. Theexpanded chondrocytes are then provided to the surgeon in the form of acell suspension or pre-loaded onto a synthetic or natural biodegradable,biocompatible scaffold for placement into the cartilage defect site.Sometimes, these living cells are placed in a three-dimensional naturalor synthetic scaffold or matrix, and are kept under tissue specificculture conditions to create a transplantable function tissuereplacement. If provided with the appropriate conditions and signals,the cells will proliferate, differentiate, and secrete various matrixmolecules to create an actual living tissue that can be used as areplacement tissue to be implanted back into the defect site in thepatient.

Other techniques for repairing damaged cartilage employ cells other thanchondrocytes to produce the desired hyaline-like tissue. Stem orprogenitor cells, such as the cells within fatty tissue, muscle, or bonemarrow, have the potential to regenerate bone and/or cartilage in apatient. Stem cells can be from that patient, i.e., autogeneic, or fromanother patient, i.e., allogeneic. These progenitor cells in addition toother cells, such as cells from the synovium, are thought to regeneratecartilage tissue when placed in an environment favorable for inducingcartilage formation.

Other surgical techniques for the surgical treatment of damaged tissueinclude the use of surgical implants, scaffolds, or matrices. Varioussurgical implants have been used in surgical procedures to helpregenerate cartilage without the use of cells. For example, implants canbe created consisting of porous biodegradable, biocompatible polymericmatrices. Other examples include matrices derived from biopolymers suchas hyaluronic acid, collagen, and fibrin. These implants are often usedin conjunction with marrow stimulation techniques, such asmicrofracture, such that the marrow can provide the cells as well asother stimulants that will help to regenerate cartilage.

Before an implant can be placed into the patient, preparations must bemade to both the defect site and the implant to ensure good integrationof the implant with the cartilage surrounding the defect. The patientmust be prepared by clearing the degenerate or damaged tissue from thedefect site. Particularly in arthroscopic procedures where access to thesurgical site is limited, clearing space at the defect site can bedifficult and time consuming in attempts to minimize any trauma to theneighboring healthy cartilage and/or subchondral bone, i.e., the boneunderlying the defect. The implant must also be prepared by sizing itfrom its laboratory-created size to match the cleared defect space inthe patient. Because the implant cannot be appropriately sized until thespace at the defect site in the patient has been formed and its size canbe identified, the implant has to be prepared for implantation ad hocduring the surgical procedure. Errors in sizing the implant during thestress of surgery can prolong the surgical procedure and can result inrepeated resizing of the tissue replacement to an acceptable size. Insome cases attempts to size the implant can result in no appropriatelysized implant if it has been cut to one or more unusable sizes. Anunusable implant can necessitate creation of another implant in anotherexpensive, time-consuming, and medically intrusive process followed byanother attempt at implantation in the patient.

Accordingly, there remains a need for methods and devices for preparinga defect site in a patient and for preparing and placing an implant intothe patient.

SUMMARY OF THE INVENTION

The present invention generally provides methods and devices forpreparing and implanting tissue scaffolds. In one embodiment, a surgicaldevice is provided that includes an inner shaft having a distal end witha cartilage-engaging element formed thereon, and an outer shaft slidablyand rotatably disposed over the inner shaft. The outer shaft has ascribing element formed on a distal end thereof and is configured toform a circular mark in tissue when the outer shaft is rotated relativeto the inner shaft. The device can have any number of variations. Forexample, the outer shaft can have an arm extending radially outward froma distal end thereof at an angle relative to a longitudinal axis of theouter shaft. The scribing element can be formed on a distal end of thearm. For another example, the cartilage-engaging element can includefirst and second spikes formed on the distal end of the inner shaft. Foryet another example, the angle can be in the range of about 20° to 70°.For yet another example, the device can include a handle formed on aproximal end of the outer shaft and/or a handle formed on a proximal endof the inner shaft.

In another aspect, a tissue repair kit is provided. In one embodiment, atissue repair kit includes a scribing device having a handle, anelongate shaft extending from the handle, and a scribing element formedon a distal end of the elongate shaft. The scribing element extendsalong an axis that is offset from a longitudinal axis of the elongateshaft, and the scribing element has a distal-most scribing edge that iscurved such that rotation of the scribing device about the longitudinalaxis of the elongate shaft is effective to cause the scribing edge toform a circular mark in tissue. The kit can also include a biocompatibletissue repair scaffold configured to be implanted in a defect site intissue.

In another embodiment, a tissue repair kit includes a scribing toolconfigured to form in tissue a circular mark having a predetermineddiameter, and a cutting template device having first and second portionsslidably coupled to one another. The first and second portions have afirst position in which the first and second portions define a circularcut-out formed therebetween and have a diameter that corresponds to thepredetermined diameter. The first and second portions also have anexpanded position in which the first and second portions define anoblong cut-out formed therebetween and having a major axis length thatis adjustable. The kit can have any number of variations. For example,the first and second portions in the expanded position can define aplurality of oblong cut-outs formed therebetween, each of the pluralityof oblong cut-outs having a major axis length that is adjustable. Foranother example, the first and second portions in the first position candefine a plurality of circular cut-outs formed therebetween, each of theplurality of circular cut-outs having a different diameter. In someembodiments, the kit can also include a plurality of scribing tools,each of the plurality of scribing tools configured to form in tissue acircular mark having a predetermined diameter corresponding to one ofthe diameters of the plurality of circular cut-outs.

In another aspect, a surgical method is provided. In one embodiment, asurgical method includes advancing a surgical device into a body of apatient to position a distal scribing tip of the device at a defect sitein tissue, rotating the surgical device about a central longitudinalaxis of the surgical device such that the distal scribing tip rotates toform a circular mark in tissue around the defect site, removing thetissue within the circular mark to form a circular cavity in the tissue,cutting a biocompatible tissue repair scaffold to have a circular shapethat corresponds to the circular mark formed in the tissue, andimplanting the biocompatible tissue repair scaffold in the circularcavity in the tissue. The method can have any number of variations. Forexample, the surgical device can be inserted through an opening intissue, and the circular mark can have a diameter that is greater than adiameter of the opening. For another example, the circular mark can havea diameter in the range of about 5 to 40 mm. For yet another example,the biocompatible tissue repair scaffold can have a viable tissuedisposed thereon. For still another example, rotating the surgicaldevice can include rotating an outer member having the distal scribingtip formed thereon relative to an inner member that engages boneunderlying the tissue.

In another embodiment, a surgical method includes rotating a scribingdevice about a longitudinal axis of the scribing device to form a firstsubstantially circular mark in tissue at a defect site, rotating ascribing device about a longitudinal axis of the scribing device to forma second substantially circular mark in the tissue at the defect site,and removing tissue within the first and second substantially circularmarks to remove a defect in the tissue. The second substantiallycircular mark partially overlaps the first substantially circular mark.The method can vary in any number of ways. For example, the method caninclude forming at least one linear mark in the tissue that extendsbetween an outer edge of the first substantially circular mark and anouter edge of the second substantially circular mark. For anotherexample, the method can include first and second linear marks in thetissue, each linear mark being tangent to the first and secondsubstantially circular marks such that the first and secondsubstantially circular marks and the first and second linear marks forman oblong mark in the tissue. For yet another example, the firstsubstantially circular mark can have a diameter that differs from adiameter of the second substantially circular mark. For still anotherexample, a first scribing device can be used to form the firstsubstantially circular mark, and a second scribing device can be used toform the second substantially circular mark. The method can also includeremoving tissue inside the first and second substantially circular marksto form a cavity in the tissue, and implanting a biocompatible tissuerepair scaffold in the cavity in the tissue. In some embodiments, priorto implanting the biocompatible tissue repair scaffold, the method caninclude measuring a maximum length of the first and second substantiallycircular marks formed in the tissue, and cutting the biocompatibletissue repair scaffold to have a size and shape that corresponds to asize and shape of the cavity in the tissue.

In yet another embodiment, a surgical method includes measuring a lengthof an oblong mark formed in tissue, slidably moving first and secondportions of a template tool to form a cut-out between the first andsecond portions that has a length that corresponds to the measuredlength of the oblong mark formed in the tissue, and using the cut-out toform a tissue repair scaffold having a size and shape that correspondsto the oblong mark formed in the tissue. The method can also includeimplanting the tissue repair scaffold in the oblong mark in the tissue.In one embodiment, the mark can be formed using a scribing toolconfigured to form in tissue a circular mark having a predetermineddiameter. In some embodiments, slidably moving first and second portionsof a template tool can include moving the first and second portions froma first position defining a first shape having a diameter equal to thepredetermined diameter to an expanded position defining a second shapethat has a length that corresponds to the measured length of the oblongmark formed in the tissue.

In still another embodiment, a surgical method includes advancing atransparent film through a passageway extending through tissue and intoa body cavity, positioning the film over a defect in a tissue surface inthe body cavity, comparing a shape of the film to a shape of the defect,removing the film from the patient, cutting the film to have a shapethat substantially corresponds to the shape of the defect, and using thecut film shape as a template to cut a tissue repair scaffold such thatthe tissue repair scaffold has a shape that substantially corresponds tothe shape of the defect. The film can have a folded configuration whendisposed within the passageway, and it can open to a planarconfiguration upon passage out of the passageway and into the bodycavity. The method can vary in any number of ways. For example, themethod can include, prior to advancing a transparent film through apassageway, selecting a transparent film from one of a plurality oftransparent films having predefined different shapes. For anotherexample, the method can include, prior to using the cut film shape as atemplate to cut a tissue repair scaffold, repeating the steps ofadvancing, positioning, comparing, removing, and cutting.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of one embodiment of an outer shaft of ascribing tool having a distal scribing arm;

FIG. 2 is a side view of the outer shaft of FIG. 1 ;

FIG. 3 is a distal end view of the outer shaft of FIG. 1 ;

FIG. 4 is a cross-sectional side view of the outer shaft of FIG. 1 and aside view of an inner shaft configured to be disposed in a passagewayextending through the outer shaft;

FIG. 5 is a distal end view of the inner shaft of FIG. 4 ;

FIG. 6 is a side view of one embodiment of a scribing tool having acurved distal scribing tip;

FIG. 7 is a partial cutaway view of the outer shaft of FIG. 1 beingadvanced through tissue of a patient;

FIG. 8A is a partial cutaway view of the inner shaft of FIG. 4 disposedin the outer shaft of FIG. 7 , and the outer shaft being rotated aroundthe inner shaft to mark a line in tissue that at least partiallysurrounds a tissue defect site;

FIG. 8B is a partial cutaway view of the inner shaft of FIG. 4 disposedin another embodiment of an outer shaft of a scribing tool having adistal scribing arm, and the outer shaft being rotated around the innershaft to mark a line in tissue that at least partially surrounds atissue defect site;

FIG. 9 is a partial cutaway view of the scribing tool of FIG. 6 advancedthrough tissue of a patient with the distal scribing tip positionedadjacent a tissue defect site;

FIG. 10 is a partial perspective view of the scribing tool of FIG. 9being rotated to mark a line in tissue that surrounds a tissue defectsite;

FIG. 11 is a top view of the scribing tool of FIG. 9 being rotated tomark a line in tissue that surrounds a tissue defect site;

FIG. 12 is a top view of one embodiment of a first circular mark intissue that partially surrounds a tissue defect site, and a secondcircular mark in tissue that overlaps a portion of the first circularmark and that partially surrounds the tissue defect site;

FIG. 13 is a top view of one embodiment of first and second circularmarks in tissue that each partially surround a tissue defect site;

FIG. 14 is a top view of one embodiment of connecting lines marked intissue to connect outer edges of the first and second circular marks ofFIG. 13 ;

FIG. 15 is a top view of one embodiment of first and second circularmarks in tissue to each partially surround a tissue defect site, andconnecting lines marked in tissue that connect outer edges of the firstand second circular marks;

FIG. 16 is a partial perspective view of one embodiment of a scraperclearing tissue from within a shape marked in tissue to form a cavity;

FIG. 17 is a partial perspective view of one embodiment of a suctiondevice suctioning tissue from within the cavity cleared by the scraperof FIG. 16 ;

FIG. 18 is a partial perspective view of the cavity of FIG. 17 withtissue cleared and suctioned from within the cavity;

FIG. 19 is a partial cutaway perspective view of the inner and outershafts of FIG. 8B being used to cut a tissue scaffold;

FIG. 20 is a perspective view of the scribing tool of FIG. 6 being usedto cut a tissue scaffold;

FIG. 21 is a partial perspective view of one embodiment of a measuringdevice measuring a size of a cavity formed in tissue;

FIG. 22 is a top view of one embodiment of an adjustable template toolin an unexpanded position;

FIG. 23 is a top view of the adjustable template tool of FIG. 22 in anexpanded position;

FIG. 24 is a top view of the adjustable template tool of FIG. 23 withtissue scaffold material positioned under at least a portion of thetemplate tool;

FIG. 25 is a top view of one embodiment of a flexible, transparent filmhaving a plurality of pre-cut shapes formed therein;

FIG. 25A is a top view of one embodiment of a flexible, transparent filmhaving a plurality of crisscrossing grid lines;

FIG. 26 is a partial perspective view of one embodiment of a flexible,transparent film being advanced through an introducer device to alocation adjacent a cavity formed in tissue of a patient;

FIG. 27 is a partial perspective view of the film of FIG. 26 positionedover the cavity formed in tissue;

FIG. 28 is a partial perspective view of a shape being cut in the filmof FIG. 27 using a scribing instrument;

FIG. 29 is a partial perspective view of the film of FIG. 28 positionedover the cavity of FIG. 26 ; and

FIG. 30 is a partial perspective view of the film of FIG. 29 positionedover tissue scaffold material, and a scribing instrument cutting thetissue scaffold material using the film as a template.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention generally provides various methods and devices forpreparing and implanting tissue replacements. In general, various toolsand techniques are disclosed for marking, e.g., scribing or scoring, oneor more predetermined shapes, e.g., circles, ovals, oblong shapes, etc.,around a defect site in tissue, e.g., cartilage. The marked tissuewithin the predetermined shape or shapes, i.e., the defective tissue,can be removed to form a cavity in the tissue. Since the shape of thecavity is known because the shape or shapes marked are predetermined, atissue scaffold can be cut having a shape and size that matches theshape and size of the cavity, thereby providing a scaffold that fillsthe entire cavity in the tissue. Various other methods and devices arealso provided for determining the shape and size of a cavity in tissue,and for preparing a tissue scaffold having a shape and size that matchesthe shape and size of the cavity.

A person skilled in the art will appreciate that the term “tissue” asused herein is intended to encompass a variety of materials, e.g.,cartilage, organs, and any other material that can be repaired using atissue scaffold, and that the term “cartilage” as used herein can referto any type of cartilage, e.g., hyaline cartilage, fibrocartilage, andelastic cartilage. A person skilled in the art will also appreciate thatthe term “defect site” as used herein is intended to encompass a currentor former location in tissue that is damaged, unhealthy, or is otherwiseundesirable and intended for repair with a tissue replacement. A personskilled in the art will also appreciate that the term “tissuereplacement,” “implant,” “scaffold,” or “matrix” as used herein isintended to encompass any surgically safe implant that is configured tobe implanted in a patient to allow for tissue repair and regrowth.

A person skilled in the art will also appreciate that while the methodsand devices are described in connection with minimally invasivearthroscopic procedures in which surgical devices are introducedpercutaneously into a body cavity through a small opening formed in apatient, the methods and devices disclosed herein can be used innumerous surgical procedures and with numerous surgical instruments. Byway of non-limiting example, the methods and devices can be used in opensurgical procedures. A person skilled in the art will also appreciatethat while the methods and devices are described in connection withchondral cartilage repair, the methods and devices can be used in othertissue repairs related to the knee, e.g., cartilage at the patella, orto other articulating surfaces, e.g., shoulder, ankle, hip, and elbow,and in any other type of tissue repair using a tissue replacementimplant.

In an exemplary embodiment, a patient having a cartilage lesion at adefect site at the articular surface of a bone joint, such as thefemoral condyle at the knee, can be prepared for tissue repair surgery.Through an arthrotomy incision, the knee joint can be opened and thedefect site exposed. The size and shape of the lesion can vary, althougha lesion at the femoral condyle traditionally has an elliptical shapehaving a surface area of about 10 cm² (1000 mm²). The undesirablecartilage tissue, which can include fibrillations and fissures, can beremoved, to form a cavity in the tissue. An amount of healthy cartilageadjacent the lesion can also be removed in the process of removing thelesion. Debridement of the articular surface can be deep enough toexpose a calcified layer of cartilage and/or a subchondral bone surface,e.g., in a range of about 2 to 3 mm below a top surface of thecartilage, for receiving a tissue repair implant. The bone surface canprovide a substantially smooth surface for placement of the implant anda stable structure to which the implant can be attached. Once thearticular surface has been properly prepared, the tissue repair implantcan be implanted into the cavity formed in the cartilage and onto thearticular surface. In some embodiments, a portion of the bone can beremoved, and the implant can be implanted into the cavity formed in thecartilage and in the bone.

Before the implant is placed into a patient, the implant can be createdusing viable tissue, e.g., living, non-destroyed tissue cells, harvestedfrom the patient in a first surgical procedure separate from a surgicalprocedure in which the implant is delivered to the patient, such as inautologous chondrocyte implantation (ACI) procedure, e.g., a procedureusing a MACI® implant (available from Genzyme Corporation of Cambridge,Mass.). Although, a person skilled in the art will appreciate that theviable tissue can also or instead be gathered during the same surgicalprocedure in which the implant is attached to the patient.

Viable tissue can be collected from the patient in any way, as will beappreciated by a person skilled in the art. Various non-limitingembodiments of methods and devices for collecting tissue from a patient,such as in a biopsy procedure, can be found in U.S. Pat. No. 7,115,100issued Oct. 3, 2006 entitled “Tissue Biopsy And Processing Device,” U.S.Patent Publication No. 2008/0234715 filed Mar. 27, 2008 entitled “TissueExtraction and Collection Device,” and U.S. Patent Publication No.2005/0059905 filed Sep. 11, 2003 entitled “Tissue Extraction andMaceration Device,” which are hereby incorporated by reference in theirentireties.

The source of viable tissue can vary, and the tissue can have a varietyof configurations, but in an exemplary embodiment the harvested tissueincludes chondrocytes. In an exemplary embodiment, once a sample ofviable tissue has been obtained, the tissue sample can be processedunder sterile conditions to create a suspension having at least oneminced, or finely divided tissue particle. It is also possible toharvest the tissue in minced form such that further processing is notnecessary. A person skilled in the art will appreciate that mincedviable tissue fragments are simply small portions of living,non-destroyed tissue and that minced tissue fragments can enhance theeffectiveness of the regrowth and healing response. The particle size ofeach tissue fragment can vary. By way of non-limiting example, thetissue size can be in the range of about 0.001 to 3 mm³, but preferablythe tissue particle is less than about 1 mm³. In another embodiment, theviable tissue can be in the form of a tissue slice or strip harvestedfrom healthy tissue that contains viable cells capable of tissueregeneration and/or remodeling, as described in U.S. Patent PublicationNo. 2005/0125077 filed Dec. 5, 2003 and entitled “Viable Tissue RepairImplants and Methods of Use,” which is hereby incorporated by referencein its entirety. The tissue slice can be harvested to have a geometrythat is suitable for implantation at the site of the injury or defect,and the harvested tissue slice can be dimensioned to allow the viablecells contained within the tissue slice to migrate out and proliferateand integrate with tissue surrounding the repair site. A person skilledin the art will appreciate that tissue can be collected from the patientand/or a compatible donor, that the tissue can be artificial tissuematerial, and that any combination of harvested tissue and artificialtissue material can be used.

Viable tissue harvested from a patient can optionally be combined with avariety of other materials, including carriers, such as a gel-likecarrier or an adhesive. The viable tissue can also be contacted with amatrix-digesting enzyme to facilitate tissue migration out of theextracellular matrix surrounding the viable tissue. The enzymes can beused to increase the rate of cell migration out of the extracellularmatrix and into the implant. Various non-limiting embodiments ofgel-like carriers, adhesives, and enzymes can be found in U.S. PatentPublication No. 2005/0177249 filed Feb. 9, 2004 entitled “Scaffolds WithViable Tissue,” which is hereby incorporated by reference in itsentirety. Other non-limiting embodiments of viable tissue sources andmethods for preparing viable tissues are disclosed in U.S. PatentPublication No. 2005/0113937 filed on Nov. 26, 2003 entitled“Conformable Tissue Repair Implant Capable Of Injection Delivery,” whichis hereby incorporated by reference in its entirety.

The viable tissue and any material combined with the viable tissue canbe loaded onto a tissue scaffold. The scaffold can have a variety ofconfigurations, as will be appreciated by a person skilled in the art.Generally, the scaffold can be formed using virtually any material ordelivery vehicle that is biocompatible, bioimplantable, easilysterilized, and that has sufficient structural integrity and/or physicaland mechanical properties to effectively provide for ease of handling inan operating room environment and to permit it to accept and retain oneor more securing mechanisms, e.g., sutures, staples, adhesive, etc.,without substantially tearing. By way of non-limiting example, thescaffold can be in the form of a matrix that is formed from a variety ofany one or more materials, including resorbable materials,non-biological materials, and/or synthetic materials. The scaffold canbe flexible so as to allow the scaffold to conform to the shape anddimensions of the target site of implantation. The scaffold can alsoinclude a bioabsorbable and/or bioresorbable component to act as atemporary carrier to improve handling of the implant duringtransportation. Various non-limiting embodiments of tissue scaffolds canbe found in previously mentioned U.S. Patent Publication No.2005/0177249 filed Feb. 9, 2004 entitled “Scaffolds With Viable Tissue,”and in U.S. Patent Publication No. 2004/0078090 filed Feb. 25, 2003entitled “Biocompatible Scaffolds With Tissue Fragments,” U.S. PatentPublication No. 2005/0038520 filed Aug. 11, 2003 entitled “Method AndApparatus For Resurfacing An Articular Surface,” and U.S. Pat. No.6,884,428 issued Apr. 26, 2005 entitled “Use of Reinforced Foam Implantswith Enhanced Integrity For Soft Tissue Repair And Regeneration,” whichare hereby incorporated by reference in their entireties.

Tissue harvested from a patient can be prepared and applied to ascaffold in any way, as will be appreciated by a person skilled in theart. The tissue component can be added to the scaffold during or aftermanufacture of the scaffold or before or after the implant is installedin a patient. Optionally, a bioactive agent can be incorporated withinand/or applied to the tissue scaffold, and/or it can be applied to theviable tissue. Preferably, the bioactive agent is incorporated within,or coated on, the scaffold prior to the addition of viable tissue to thescaffold. The bioactive agent(s) can be selected from among a variety ofeffectors and cells that, when present at the site of injury, promotehealing and/or growth or regeneration of the affected tissue. Variousnon-limiting embodiments of effectors and cells can be found inpreviously mentioned U.S. Patent Publication No. 2005/0177249 filed Feb.9, 2004 entitled “Scaffolds With Viable Tissue.” Various non-limitingembodiments of applying tissue, e.g., minced viable tissue, to ascaffold can be found in U.S. Patent Publication No. 2004/0193071 filedMar. 28, 2003 entitled “Tissue Collection Devices And Methods,” which ishereby incorporated by reference in its entirety.

As mentioned above, once a tissue scaffold is available for implantationinto a patient, the patient can be prepared for the scaffold'simplantation by removing cartilage to create a hole or cavity in thecartilage that extends from a surface of the cartilage to the underlyingfemoral condyle, or other site, as mentioned above. The defect site canbe prepared for scaffold implantation in a variety of ways. In anexemplary embodiment, a surgical scribing tool configured to mark apredetermined shape in tissue can be arthroscopically used to form a cuthaving a predetermined shape in the cartilage such that the marked shapeencloses the lesion, as discussed further below. Cartilage can beremoved from within the marked shape such that the marked shape candefine a perimeter of the tissue cavity in which the scaffold can beimplanted. In some embodiments, also discussed further below, thescribing tool can be used to mark multiple shapes in the cartilage, eachof the shapes overlapping at least a portion of the lesion andoptionally overlapping at least one additional marked shape. The shapescan also be altered and/or connected using the same and/or additionalscribing tools. The cartilage within the combined marked shape can beremoved to define the shape of the scaffold-receiving cavity.

FIGS. 1-5 illustrate one exemplary embodiment of a compass-stylesurgical scribing tool 10 configured to mark, e.g., slice, score, etc.,a predetermined circular shape in tissue. The scribing tool 10 can alsobe configured to cut tissue. The scribing tool 10 includes an outershaft 12 and an inner shaft 14 configured to be movable relative to oneanother. Generally, the outer shaft 12 can be configured to rotateclockwise and/or counterclockwise around the inner shaft 14 when theouter shaft 12 is disposed in an inner passageway 16 of the outer shaft12 such that a distal scribing tip 18 of the outer shaft 12 can move ina circle and mark a circular shape when positioned against tissue.

The outer shaft 12 can have a variety of shapes and configurations. Asshown in this embodiment, the outer shaft 12 includes an elongate body20 having a handle 22 at a proximal end 12 a of the outer shaft 12 andan angled arm 24 offset from the elongate body 20 at a distal end 12 bof the outer shaft 12. The elongate body 20 can be substantiallycylindrical-shaped, as shown, although the elongate body 20 can have anyshape. The elongate body 20 can also have any size such that itslongitudinal length can allow at least a portion of the outer shaft 12to be inserted into a body cavity of a patient with at least the handle22 being located outside the patient. The inner passageway 16 can extendlongitudinally through the elongate body 20 and can have any size andshape, e.g., cylindrically-shaped, configured to allow the inner shaft14 to be slidably disposed therein and for the outer shaft 12 to rotatearound the inner shaft 14 when the inner shaft 14 is disposed in thepassageway 16.

The handle 22 is illustrated as being located at a proximal-most end ofthe outer shaft 12, but the handle 22 can be located anywhere at theouter shaft's proximal end 12 a. The handle 22 can be, for non-limitingexample, a substantially cylindrical disc or knob as shown, although aswill be appreciated by a person skilled in the art the handle 22 canhave any size, shape, and configuration that allows the outer shaft 12to be held outside the body. The illustrated disc or knob shape of thehandle 22 can allow the handle 22 to be manipulated using one hand,which can free the other hand for other surgical tasks. The handle 22can be held and manipulated to help insert the outer shaft 12 into apatient, rotate the outer shaft 12 within the patient, and remove theouter shaft 12 from the patient. The passageway 16 can extend throughthe handle 22 to allow the inner shaft 14 to be slidably disposedtherein. A diameter D1 of the passageway 16 can therefore be smallerthan a diameter D2 of the handle 22. In some embodiments, such as if thehandle is configured as a grippable handhold extending at a non-zeroangle from one or more discrete locations around a perimeter of theelongate body 20, the passageway 16 can be separate from the handle 22.The diameter D2 of the handle 22 can also be larger than a diameter D3of the elongate body 20, which can help the handle 22 serve as a stopmechanism configured to prevent the outer shaft 12 from being fullydistally advanced into a body of a patient through an opening used toinsert a distal portion of the outer shaft 12 into the patient's body.The passageway 16, the handle 22, and the elongate body 20 can share acentral longitudinal axis A, which can help the outer shaft 12 rotatearound the central longitudinal axis A when the handle 22 is moved torotate the outer shaft 12, as discussed further below. A person skilledin the art will appreciate that while the handle 22 can make the outershaft 12 easier to manipulate, the outer shaft 12 need not include thehandle 22 but instead be manipulated using, e.g., a proximal end of theelongate body 20.

The angled arm 24 can distally extend from the elongate body 20 at anyangle α. The angle α can be non-zero and less than about 90°, e.g., in arange of about 20° to 70°, to allow the distal scribing tip 18 at adistal end of the arm 24 to form a distal-most end of the outer shaft12. The distal scribing tip 18 can thus contact a tissue positioneddistal to the outer shaft 12 without any other portion of the outershaft 12 also contacting the tissue.

The arm 24 can have any longitudinal length with the distal scribing tip18 radially extending a distance r from the central longitudinal axis A.The distance r thus can correspond to a radius of a circle formed by thedistal scribing tip 18 when the outer shaft 12 is rotated around thecentral longitudinal axis A such that a center of the circle can beaxially aligned with the central longitudinal axis A. In an exemplaryembodiment, the distance r can be in a range of about 2.5 to 20 mm(about 5 to 40 mm diameter), e.g., about 5 to 10 mm (about 10 to 20 mmdiameter).

Although the arm 24 is shown integrally formed with the elongate body20, in some embodiments, the arm 24 can be a modular element configuredto be removably coupled to the elongate body 20 in any way appreciatedby a person skilled in the art, e.g., threadably attached, snap fit,etc. Modular arms can optionally be supplied with an outer shaft of ascribing tool as part of a kit, which can also include an inner shaft.In this way, arms of different sizes, e.g., having different radialdistances r, can be coupled to the elongate body 20 to allow the outershaft 12 to mark circles of different diameters during the same ordifferent surgical procedures. The distance r can be varied by changinga longitudinal length of the arm 24 and/or the angle α between the arm24 and the elongate body 20. The distance r can also be changed bymanipulating the arm's longitudinal length, e.g. pushing out the arm 24or changing the angle α, without replacing the arm 24, such as with aretractable arm having umbrella-type folds. In another embodiment, thecam mechanism can be in the form of a rigid wire guided to enter andexit the elongate body 20 at predetermined angles that are notnecessarily the same. For non-limiting example, the wire can enter theelongate body 20 parallel to the central axis A. By controlling the feedof the wire into the elongate body 20, the distance r can bemanipulated. A cam mechanism (not shown) can optionally be included withthe arm to vary the distance r, which can allow non-circular, e.g.,ovular, marks to be made using the arm.

The distal scribing tip 18 can have a variety of sizes, shapes, andconfigurations. The distal scribing tip 18 can generally include ascribing edge, e.g., a knife blade, a needle, a water jet, a bovie, aharmonic scalpel, etc., configured to mark tissue. The distal scribingtip 18 can have a non-circular scribing edge such that the scribing tip18 can be used as a stylus configured to “draw” a line, such as a lineforming a circumference of a circle. The distal scribing tip 18 can beconfigured to be sharp enough to cut through tissue but not sharp enoughto significantly cut bone underlying tissue to help minimize damage tothe bone. The distal scribing tip 18 can be configured to mark a linehaving any width w, such as a thin line having a width of a traditionalknife edge, e.g., about 0.2 mm, or a thicker line or trough having alarger width, e.g., about 3 mm. A larger scribing tip width w can allowthe outer shaft 12 to mark more cartilage and thereby reduce an amountof cartilage to be cleared from within the shape defined by a linemarked by the distal scribing tip 18.

The inner shaft 14 can also have a variety of configurations. As shownin this embodiment, the inner shaft 14 includes an elongate body 26having a handle 28 at a proximal end 14 a of the inner shaft 14 and atleast one cartilage-engaging element 30 at a distal end 14 b of theinner shaft 14. The inner shaft 14 can have any longitudinal length, butin an exemplary embodiment the inner shaft 14 can be longer than theouter shaft 12 to allow the inner shaft 14 to be disposed in thepassageway 16 and simultaneously distally extend beyond the outershaft's distal end 12 b and proximally extend beyond the outer shaft'sproximal end 12 a. The handle 28 can be similar to the outer shaft'shandle 22, although the handles 22, 28 can be different from each otherand need not be the same as shown in the scribing tool 10.

As mentioned above, the inner shaft 14 can be configured to be removablycoupled to the outer shaft 12 with the inner shaft's elongate body 26slidably received within the inner passageway 16 of the outer shaft 12.The inner shaft's elongate body 26 can thus, as shown in thisembodiment, be substantially cylindrical-shaped to match the shape ofthe inner passageway 16. The outer shaft's passageway 16 and the innershaft's elongate body 26 having corresponding cylindrical shapes canallow the inner shaft 14 to be both linearly and rotatably movablewithin the inner passageway 16. The inner shaft's elongate body 26 canthus have a diameter D4 less than the diameter D1 of the outer shaft'sinner passageway 16 to allow the elongate body 26 to be movable therein.Conversely, the inner shaft's handle 28 can have a diameter D5 that isgreater than the diameter D1 of the outer shaft's passageway 16 andgreater than the elongate body's diameter D4. In this way, the innershaft's handle 28 can serve as a stop mechanism, similar to the stopmechanism discussed above, configured to limit a distance that thedistal end 14 b of the inner shaft 14 extends beyond the distal end 12 bof the outer shaft 12.

Although the inner shaft 14 can be a solid member as shown, the innershaft 14 can include one or more passageways formed therethrough. Fornon-limiting example, the inner shaft 14 can include a tunnel extendingthrough its distal and proximal ends 14 b, 14 a that is configured toreceive at least one surgical instrument disposed therethrough, e.g., avacuum device configured to suction fluid, tissue, etc. away from asurgical site.

The one or more cartilage-engaging elements 30 at the inner shaft'sdistal end 14 b can generally be configured to help secure the innershaft 14 against cartilage and/or bone when the inner shaft 14 isdisposed through the outer shaft 12. In an exemplary embodiment, thecartilage-engaging elements 30 can be configured to contact cartilagewithout penetrating into bone to help avoid inflicting any damage to thebone. In some embodiments, the cartilage-engaging elements 30 can beconfigured to not contact bone at all but only contact cartilage orother tissue to help stabilize the inner shaft 14. Thecartilage-engaging elements 30 can have any size, shape, andconfiguration. Although two cartilage-engaging elements 30 are shown,the inner shaft 14 can include any number of cartilage-engaging elements30. Moreover, each of the cartilage-engaging elements 30 can be the sameor different from any other of the cartilage-engaging elements 30. Thecartilage-engaging elements 30 can be configured as spikes or prongs asshown, with or without tapered distal tips configured to help thecartilage-engaging elements 30 penetrate bone. The cartilage-engagingelements 30 can be arranged at the inner shaft's distal end 14 b in anyconfiguration, such as equidistantly spaced radially around a centrallongitudinal axis A2 of the inner shaft 14, as illustrated. In anembodiment where the inner shaft has a single cartilage-engagingelement, the single cartilage-engaging element can be substantiallyaxially aligned with the central longitudinal axis A2. In someembodiments including a plurality of the cartilage-engaging elements 30,the cartilage-engaging elements 30 can cover a distal end surface of theelongate body 20 such that the cartilage-engaging elements 30, e.g., aplurality of teeth, can form a textured cartilage-engaging surfaceconfigured to grip cartilage and/or bone without penetrating into thecartilage and/or bone.

Although the cartilage-engaging elements 30 are shown integrally formedwith the elongate body 26, any one or more of the cartilage-engagingelements 30 can be movably coupled to the elongate body 26. Fornon-limiting example, the cartilage-engaging elements 30 can beretractable such that in an extended position the cartilage-engagingelements 30 can extend distally beyond the inner shaft's distal end 14 band in a retracted position can be contained within the elongate body26. Retraction and extension of movable cartilage-engaging elements canbe controlled in any way, as will be appreciate by a person skilled inthe art, such as through actuation of a control mechanism, e.g., a knob,a button, a lever, an electronic signal communicator, etc., at theproximal end 14 a of the inner shaft 14.

FIG. 6 illustrates another embodiment of a scribing tool. In thisembodiment, the tool is a wood cutter-style surgical scribing tool 50configured to mark a circular shape in tissue. The scribing tool 50 caninclude a proximal handle portion 52 and a distal shaft portion 54. Thehandle portion 52 can include any type of handle as will be appreciatedby a person skilled in the art, such as a cylindrical hand grip asshown. The handle portion 52 can optionally include one or more grippingmechanisms, e.g., finger loops, molded finger depressions, treads, etc.,to help a hand hold and rotate the scribing tool 50. The shaft portion54 can include a shaft 56 extending distally from the handle portion 52and having a distal scribing tip 58 at a distal end of the shaft 56.Generally, the scribing tool 50 can be rotated clockwise and/orcounterclockwise around a longitudinal axis of the scribing tool 50,e.g., a central, proximal longitudinal axis A2, such that the distalscribing tip 58 can move in a circle around the longitudinal axis A2 andmark a circular shape when the distal scribing tip 58 is positionedagainst tissue.

The shaft 56 can have any configuration. The shaft 56 can include arigid elongate member having a distal portion 56 c that is radiallyoffset from a proximal portion 56 a with an angled mid-portion 56 blocated between the proximal and distal portions 56 a, 56 c. The shaft'sdistal portion 56 c can be offset by any radial distance d and at anyangle ß from the proximal portion 56 a. As shown in the illustratedembodiment, the mid-portion 56 b can distally extend from the proximalportion 56 a at the angle ß, and the distal portion 56 c can distallyextend from the mid-portion 56 b at the angle ß such that thelongitudinal axis A2 of the proximal portion 56 a can be parallel to alongitudinal axis A3 of the distal portion 56 c. In this way, thescribing tool 50 can be rotated with the distal scribing tip 58 mosteffectively positioned to mark the tissue. The shaft 56 can extend froma center of the handle portion 52 as illustrated such that thelongitudinal axis A2 of the handle portion 52 axially aligns with thelongitudinal axis of the proximal portion 56 a of the shaft 56. In thisway, a center of a circle marked by the distal scribing tip 58 can haveits center substantially aligned with the longitudinal axis A2 of thescribing tool 50.

Although the shaft 56 is shown integrally formed with the handle portion52, in some embodiments, the shaft 56 can be a modular elementconfigured to be removably coupled to the handle portion 52 in any wayappreciated by a person skilled in the art, e.g., threadably attached,snap fit, etc. In this way, shafts of different sizes, e.g., configuredto mark circles having different radii, can be coupled to the handleportion 52. Modular shafts can optionally be supplied with a handleportion as part of a kit.

Although the shaft 56 can be a solid member as shown, the shaft 56 caninclude one or more passageways formed therethrough. For non-limitingexample, the shaft 56 can include a tunnel extending through at leastits proximal portion 56 a that is in communication with a tunnelextending through the handle portion 52. The shaft and handle portion'stunnel can be configured to receive at least one surgical instrumentdisposed therethrough, e.g., a vacuum device configured to suctionfluid, tissue, etc. away from a surgical site or a stabilizing tool suchas the inner shaft 14, or a positioning tool configured to penetratebone to aid the tool 50 in rotating about its axis A2.

The shaft 56 can also have any size and shape. As illustrated in thisembodiment, the shaft 56, or at least the distal portion 56 c thereof,can be in the form of a bar or rod having an arcuate, c-shapedcross-sectional shape. The distal scribing tip 58 can thus have anarcuate, c-shaped cross-sectional shape configured to allow the scribingtool 50 to mark a circle in tissue when the scribing tool 50 is rotatedabout the longitudinal axis A2 of the scribing tool 50. In someembodiments, the shaft 56 can have one or more other cross-sectionalshapes in addition to or instead of a c-shape along its length, e.g.,circular, square, triangular, etc., provided that a scribing edge of thedistal scribing tip 58 has an arcuate shape.

The distal scribing tip 58 can have a variety of sizes, shapes, andconfigurations, similar to that discussed above regarding the distalscribing tip 18 of the scribing tool 10. The distal scribing tip 58 canhave any radius of curvature configured to mark a line forming acircumference of a circle having a radius equal to the radius ofcurvature of the distal scribing tip 58. In an exemplary embodiment, theradius of curvature of the distal scribing tip 58 can be in a range ofabout 2.5 to 20 mm, e.g., about 5 mm. The curvature of the distalscribing tip 58 can help guide the distal scribing tip 58 in a circularmotion when the scribing tool 50 is rotated about the centrallongitudinal axis A2, as discussed further below. The scribing tool 50can optionally include a center pin (not shown) axially extending fromthe proximal portion 56 a of the shaft and/or the handle 52 that isconfigured to penetrate cartilage and stabilize the tool 50 withoutpreventing rotational motion of the tool 50 to allow a circular mark tobe created using the distal scribing tip 18.

Regardless of the scribing tool introduced into a body of a patient tomark at least one circle in tissue, the scribing tool can be introducedinto the patient's body in any way, as will be appreciated by a personskilled in the art. In one embodiment illustrated in FIG. 7 , a scribingtool, e.g., the scribing tool 10, can be inserted into a body cavitythrough a surgically created incision or opening 34 in a tissue 32.Although only the outer shaft 12 is shown being initially introducedthrough the tissue 32, a person skilled in the art will appreciate theinner shaft 14 can be introduced through the tissue 32 before, with, orpreferably after, the outer shaft 12. A person skilled in the art willalso appreciate that the scribing tool 10 can be inserted directlythrough the tissue 32 as illustrated, or the scribing tool 10 can beinserted through an introducer device, e.g., a surgical instrument suchas a cannula, a trocar, an endoscope, etc. that has a working channelthrough which another surgical instrument can be advanced.

Introducing the outer shaft 12 into the patient before the inner shaft14, or with the inner shaft 14 only partially advanced into thepassageway 16, can allow the outer shaft's distal arm 24 to be insertedfirst through the tissue 32 at an angle such that the opening in tissuecan have a size less than the diameter of the circular mark to be formedusing the distal scribing tip 18. The distal scribing tip 18 can helpform the opening 34 and/or one or other surgical tools can be used toform the opening 34, as will be appreciated by a person skilled in theart. Because the distal arm 24 can have a width that is smaller than itslongitudinal length r, the diameter D3 of the outer shaft's elongatebody 20, the diameter D1 of the outer shaft's passageway 16, and thediameter D4 of the inner shaft's elongate body 26, it can thus beinserted through an incision having a diameter D6 of about the arm'swidth. The arm 24 can optionally be used to widen the opening 34 as theouter shaft 12 is advanced therethrough. The outer shaft's elongate body20 can expand the diameter of the opening 34 to about the diameter D3 ofthe outer shaft's elongate body 20 as the elongate body 20 is passedtherethrough, thereby helping to minimize the size of the opening 34 andto reduce patient trauma.

The outer shaft 12 can be longitudinally advanced any distance throughthe tissue 32 and positioned in any way relative to the tissue 32. Theouter shaft 12 can also be positioned in any way relative to the tissuedefect site desired to be mark using the scribing tool 10. In anexemplary embodiment, the outer shaft 12 can be positioned through thetissue 32 such that its longitudinal axis A is substantiallyperpendicular to the defect site. Such substantially perpendicularpositioning can help more accurately position the arm 24 from outsidethe patient's body with respect to tissue and move the arm 24 morequickly and easily to mark the target tissue.

Once the outer shaft 12 has been passed through the tissue 32 with,e.g., the elongate body 20 positioned within the opening 34 with thehandle 22 and the arm 24 on opposed sides of the tissue 32, the innershaft 14 can be advanced into the passageway 16 through the outershaft's proximal end 12 a. The central longitudinal axes A, A2 of theouter and inner shafts 12, 14, respectively, can be substantiallyaligned and positioned at a desired location relative to the tissuedefect site. The inner shaft's cartilage-engaging elements 30 can extendthrough tissue at the defect site and engage bone to provide friction tohelp mount the scribing tool 10 in a stable position for scribing tissueusing the distal scribing tip 18. Bone surfaces can be non-planar, so ifthe cartilage-engaging elements 30 are configured with sharp tips topenetrate into bone, the cartilage-engaging elements 30 can bepenetrated into bone at varying depths, and/or one or more of thecartilage-engaging elements 30 may not penetrate bone at all.

With the scribing tool 10 advanced through the tissue 32 and the innershaft 14 engaging bone as desired, as illustrated in one embodiment inFIG. 8A, the outer shaft 12 can be rotated around the inner shaft 14,relative to the inner shaft 14 and a defect site 36 in cartilage 40, torotate the arm 24 around the longitudinal axes A, A2 of the outer andinner shafts 12, 14, respectively. The outer shaft 12 can be manuallyrotated, e.g., with a hand holding the handle 22, and/or electronicallyrotated, such as in robotic surgery. The inner shaft 14 can be presseddown against bone underlying the defect site 36 during rotation of theouter shaft 12 to help stabilize the scribing tool 10. The rotation ofthe arm 24 can mark a line 38 in the cartilage 40 using the distalscribing tip 18. The arm 24 can be rotated about 360° so that the markedline 38 can form a closed path that defines a circumference of a circlehaving a radius r equal to the arm's length r. The marked circle canthus have a diameter greater than the diameter D6 of the opening 34through which the scribing tool 10 was introduced into the patient. Aperson skilled in the art will appreciate that the arm 24 can becontinuously rotated about 360° in one direction, e.g., counterclockwiseas shown, or rotated any number of degrees clockwise and/orcounterclockwise to mark a circle in the cartilage 40. As mentionedabove, the line 38 can be scored any depth through the cartilage 40toward bone underlying the cartilage 40. In an exemplary embodiment, thedistal scribing tip 18 can be distally pushed until it is felt tocontact bone to help the distal scribing tip 18 cut through thecartilage 40 down to bone to help ease removal of the cartilage 40within the shape defined by the line 38. Because the outer shaft 12 canslide linearly relative to the inner shaft 14 in addition to movingrotationally around the inner shaft 14, the outer shaft 12 can slide upand down during its rotation around its central longitudinal axis A.Such slidable linear motion can allow the outer shaft 12 to compensatefor a non-planar surface of the cartilage 40 and/or the bone underlyingthe cartilage 40 and continuously score the line 38 in the cartilage 40.

FIG. 8B illustrates an alternate embodiment of a compass-style scribingtool 10′ scribing cartilage 40′ through to a bone surface 42. Thescribing tool 10′ includes an outer shaft 12′ configured to slidablyreceive an inner shaft 14′ therethrough, similar to the outer and innershafts 12, 14 of scribing tool 10. The outer shaft 12′ in this alternateembodiment, however, has a linear arm 24′ at its distal end 12 b′. Thelinear arm 24′ does not include a bend at its distal end as in the arm24 of the scribing tool 10 but instead has a pointed distal scribing tip18′. The pointed distal scribing tip 18′ can be configured to mark athin line in the cartilage 40′.

As mentioned above, the wood cutter-style scribing tool 50 can beintroduced into a body of a patient in any way and can be used to mark acircle in tissue in a way similar to the compass-style scribing tool 10.FIG. 9 illustrates one embodiment of the scribing tool 50 in an initialposition extending through a surface tissue 60 and having its distalscribing tip 58 positioned adjacent tissue, e.g., cartilage 62, to bemarked using the scribing tool 50. In an exemplary embodiment, thescribing tool 50 can be positioned through the tissue 60 such that thescribing tool's longitudinal axis A2 and the shaft's distal longitudinalaxis A3 are substantially perpendicular to the defect site. The handleportion 52 can be positioned on an opposite side of the surface tissue60 than at least a portion of the shaft 56, e.g., the distal portion 56c and the mid-portion 56 b, which can help minimize a size of an opening61 in the tissue 60 through which the scribing tool 50 is inserted sincethe handle portion 52 can be larger than the shaft portion 54.

With the scribing tool 50 advanced through the tissue surface 60 and thedistal scribing tip 58 positioned adjacent the cartilage 62, thescribing tool 50 can be rotated to mark a circular line in the cartilage62. The scribing tool 50 can be rotated generally similar to therotation described above regarding the scribing tool 10. As illustratedin one embodiment in FIGS. 10 and 11 , the scribing tool 50 can berotated about 360° around the central longitudinal axis A2, relative tothe cartilage 62, to mark a line with the distal scribing tip 58 thatforms a circular shape 66 around a defect site 64 in the cartilage 62.The circular shape 66 has a radius r2 equal to the radius of curvatureof the distal scribing tip 58.

In some instances, a defect site can have a diameter larger than adiameter of a circle that the scribing tool used to mark a circle aroundthe defect site can mark, or it can have an oblong shape making itundesirable to mark a single circle around since too much healthy tissuewill be removed. Thus, as mentioned above, in some embodiments, ascribing tool such as any of the scribing tools 10, 10′, 50, can be usedto mark two or more circular shapes in tissue at a defect site to definea shape having a non-circular perimeter. If it is known that a pluralityof circles that each partially overlap the defect site will be marked intissue, a person skilled in the art will appreciate that any one or moreof the circles can be partially marked in tissue, e.g., marked asc-shaped lines, such that the marked lines can form the non-circularperimeter shape in a similar way that the lines would form thenon-circular perimeter shape were they marked as circular-shaped lines.The same scribing tool can be used to mark each of the circles to helpminimize introduction and removal of surgical instruments into and outof the patient during the surgical procedure, although differentscribing tools can be used. As shown in one embodiment of a mosaicplastyapproach in FIG. 12 , a plurality of marked circles, e.g., first andsecond circles 70 a, 70 b, can be marked in tissue to surround a tissuedefect site 72 with each of the marked circles 70 a, 70 b partiallyoverlapping at least one other marked circle 70 a, 70 b. Although twomarked circles 70 a, 70 b are illustrated, a person skilled in the artwill appreciate that any number of overlapping circles can be marked intissue to ensure that the defect site 72 is enclosed by the markedcircles 70 a, 70 b. A person skilled in the art will also appreciatethat while the marked circles 70 a, 70 b are shown with the first circle70 a having a first radius r3 that is smaller than a second radius r4 ofthe second circle 70 b, any of the plurality of marked circles can havea radius that is the same or different as any one or more of the othermarked circles. The overlapping circles 70 a, 70 b can be marked in anyorder with respect to one another.

In some embodiments, multiple circles can be marked in tissue to overlapopposed ends of a tissue defect site. Such an approach can be effectiveto help mark an ovular or oblong shape in tissue, which can beparticularly useful in repairing a chondral defect since chondral defectsites can often have a generally ovular or oblong shape. FIGS. 13 and 14illustrate an exemplary embodiment of an ovular-mark approach. First andsecond circles 74 a, 74 b can be marked in tissue to partially overlap agenerally ovular or oblong-shaped tissue defect site 76 at opposed endsof the defect site 76, as illustrated in FIG. 13 . The first and secondcircles 74 a, 74 b can be marked in any order with respect to oneanother. A person skilled in the art will appreciate that while themarked circles 74 a, 74 b are shown with the first circle 74 a having afirst radius r5 that is smaller than a second radius r6 of the secondcircle 74 b, the first and second circles 74 a, 74 b can have a radiusthat is the same or different from one another. For non-limitingexample, FIG. 15 illustrates an exemplary embodiment of first and secondnon-overlapping circles 78 a, 78 b having a same radius r7 marked atopposed ends of an ovular tissue defect site 80. A person skilled in theart will also appreciate that while the first and second circles 74 a,74 b of FIGS. 13 and 14 are not overlapping as shown in this embodiment,marked circles at opposed ends of a tissue defect site can partiallyoverlap each other.

With circles marked to overlap opposed ends of a tissue defect site,lines can be marked in the tissue around the defect site to connect thetwo circles. With the first and second circles 74 a, 74 b marked atopposed ends of the defect site 76, first and second connecting lines 75a, 75 b can be marked in the tissue to connect the first and secondcircles 74 a, 74 b. The first and second circles 74 a, 74 b and firstand second lines 75 a, 75 b can together define a perimeter of an ovularshape marked in the tissue that surrounds the defect site 76. The firstand second lines 75 a, 75 b can be formed in tissue in any order and inany way using any surgical instrument configured to marked tissue with ascribing edge, as will be appreciated by a person skilled in the art.The first and second lines 75 a, 75 b can each be linear as illustratedwith each of the lines 75 a, 75 b tangent to each of the first andsecond circles 74 a, 74 b, or one or both of the lines 75 a, 75 b can benon-linear and/or non-tangent. Similarly, referring to FIG. 15 , firstand second connecting lines 79 a, 79 b can be marked around the defectsite 80 to connect the first and second circles 78 a, 78 b and form anoblong shape around the defect site 80.

Once a desired one or more circles have been marked around a tissuedefect site and, optionally, connecting lines are marked to connectmarked circles, the tissue within the perimeter defined by the markedcircle(s) and lines can be removed. Such removal can clear the defectfrom the tissue, potentially along with a minimal amount of healthytissue adjacent the tissue defect site, to form a cavity in the tissuefor receipt of a tissue replacement implant. The tissue within theshape's perimeter can be cleared in any way using any surgical tool,e.g., a curette, a scraper, the distal scribing tip 58 of the scribingtool 50, etc., as will be appreciated by a person skilled in the art,such as by creating a perpendicular edge between the tool and the tissueto be cleared. FIG. 16 illustrates one embodiment of tissue within acircular shape 82 marked in cartilage 84 being cleared using aflat-edged scraper 86. FIG. 17 shows excess cartilage scraped fromwithin the circle 82 being suctioned away from the surgical site using asuction device 87, which can be any surgical device configured to vacuumor suction away tissue, as will be appreciated by a person skilled inthe art. As shown in FIG. 18 , a cavity 90 defined by the perimeter orcircumference of the shape marked in the cartilage 84 can be formed inthe cartilage 84 down to bone 90 underlying the cartilage 84 aftertissue has been removed from within the shape.

With tissue cleared as desired from within the marked shape to form acavity, a tissue replacement implant can be prepared for delivery to andfastening within the cavity. The implant is traditionally created largerthan an expected size of the cavity, e.g., a size larger than the defectsite, and cut during the surgical procedure down to a size and shapesubstantially matching the cavity. In this way, the implant can be cutfrom a portion of the prepared tissue replacement implant that includesa high concentration of deposited tissue, as tissue traditionallyadheres in varying concentrations across a tissue replacement implant.Moreover, the size of the cavity formed during a surgical procedure canbe greater or less than expected, e.g., if the defect site is largerthan previously determined, if more healthy tissue is removed thanoriginally intended, etc. Cutting the implant to size during theprocedure can thus help match the implant's size to the cavity's actualsize to form a close fit and fill the entire cavity.

The tissue replacement implant can be trimmed to a desired size in anynumber of ways. In an exemplary embodiment, a tissue replacement implantcan be cut from a larger prepared implant using a scribing tool that wasused to mark at least one circle in the tissue to receive the implant.In one embodiment shown in FIG. 19 , the compass-style scribing tool 10′of FIG. 8B can be used to cut a line 100 in a prepared tissuereplacement implant 102 to form a circular shape in a similar way to howthe scribing tool 10′ can mark a circular shape in tissue. In anotherembodiment shown in FIG. 20 , the wood cutter-style scribing tool 50 ofFIG. 6 can cut a line 104 in a prepared tissue replacement implant 106to form a circular shape in a similar way to how the scribing tool 50can mark a circular shape in tissue. Using the same scribing tool tomark the cavity's shape and to cut the implant can help substantiallymatch the size of the cavity and the size of the implant. A personskilled in the art will appreciate that while the same individualscribing tool can be used to form the cavity's shape and the implant, adifferent but similarly configured scribing tool, such as a punch, canbe used that is configured to cut a circle of the same predetermineddiameter as the scribing tool used to cut the cavity's shape. Using adifferent but similarly configured scribing tool can be cleaner andfaster than using the same scribing tool, although chances of size errorcan be reduced by using the same device on both the tissue and theimplant.

In another exemplary embodiment, a template tool can be used to help cuta desirably sized tissue replacement implant. The template tool can havea variety of configurations and can be used in a variety of ways to sizean implant. Prior to using the template tool to help cut the implant, asize of the cavity formed at the defect site in tissue can be measured.In one embodiment shown in FIG. 21 , a cavity 110 cut in tissue 118 inany way can be measured using a measuring device 112 to determine a sizeof the cavity 110. The measuring device 112 can be configured to gauge adistance between at least two points in a body of a patient, e.g., anelongate shaft having markings 116 that are configured to be introducedinto the patient through an introducer device 114. The cavity 110 can bemeasured in a first direction along a major axis M1 of the cavity 110 todetermine a length of the cavity 110 and/or in a second direction alonga minor axis M2 of the cavity 110 to determine a width of the cavity110. The length of the cavity 110 along the minor axis M2 can, however,be predetermined prior to formation of the cavity 110, such as whenopposed ends of the cavity 110 are formed using a scribing toolincluding a distal scribing tip configured to cut a circle having apredetermined radius, e.g., any of the scribing tools 10, 10′, 50.Further, if the cavity 110 is circular, instead of ovular as shown inFIG. 21 , a person skilled in the art will appreciate that the major andminor axes M1, M2 would be identical and their lengths determined withone diameter or radius measurement, unless such a measurement is nottaken because the cavity's radius is known as a predetermined value. Aperson skilled in the art will also appreciate that measurements of thecavity 110 can be exact or approximate. By knowing a length and width ofthe cavity 110, or simply its diameter or radius, a tissue replacementimplant can be cut to a size and shape to substantially match the sizeand shape of the cavity 110.

In an exemplary embodiment using a template tool to help size a tissuereplacement implant, the template tool have an adjustable template toolwith at least one adjustable opening. As shown in one embodiment inFIGS. 22 and 23 , an adjustable template tool 120 can include first andsecond movable members 122, 124 configured to define a plurality ofadjustable openings 126 a, 126 b, 126 c, 126 d. Although first, second,third, and fourth openings 126 a, 126 b, 126 c, 126 d are shown, thetemplate tool 120 can include any number of adjustable openings. Thefirst and second movable members 122, 124 can be configured to bemovable relative to one another with both of the movable members 122,124 being movable, although a person skilled in the art will appreciatethat only one of the movable members 122, 124 can be configured to movewhile the other of the movable members 122, 124 remains stationary.

In this illustrated embodiment, the second movable member 124 can belinearly slidably movable relative to the first movable member 122. Thesecond movable member 124 can be linearly slidably movable in any, suchas by being slidable in a plane parallel to or co-planar with a plane ofthe first movable member 122 along connecting rods 128 a, 128 b couplingthe first and second movable members 122, 124. The template tool 120 isshown in an unexpanded position in FIG. 22 where each of the openings126 a, 126 b, 126 c, 126 d have a circular shape. Moving the first andsecond movable members 122, 124 relative to one another can move thetemplate tool 120 from the unexpanded position to an expanded positionshown in FIG. 23 where each of the openings 126 a, 126 b, 126 c, 126 dhave an oblong shape. A person skilled in the art will appreciate thatthe openings 126 a, 126 b, 126 c, 126 d can be simultaneously adjustedin size as illustrated in this embodiment, or any one or more of theopenings 126 a, 126 b, 126 c, 126 d can be adjusted individually orconcurrently with any number of the other openings 126 a, 126 b, 126 c,126 d.

The template tool 120 can be configured to size a variety of openingseach having a different minor axis length, e.g., openings created usingscribing tools having different predetermined radii. In the illustratedembodiment, each of the openings 126 a, 126 b, 126 c, 126 d can becircular shaped having a different respective radius r_(a), r_(b),r_(c), r_(d) when the template tool 120 is in the unexpanded position.By sliding the second movable member 124 any distance linearly away fromthe first movable member 122 to move the template tool 120 to anexpanded position, the size of each of the openings 126 a, 126 b, 126 c,126 d can be increased with a minor axis length of each of the openings126 a, 126 b, 126 c, 126 d remaining constant, e.g., opposed ends of theoval shape having a predetermined radius of curvature, but with a majoraxis length of each of the openings 126 a, 126 b, 126 c, 126 dincreasing. Thus, using the second opening 126 b as a non-limitingexample, a length l_(b1) of the second opening 126 b, equal to doublethe circular radius r_(b), can be increased to an expanded length l_(b2)as the second opening 126 b changes shape from a circle in theunexpanded position to an oval in the expanded position.

The template tool 120 can optionally include size identifiers 130configured to identify the radius of each of the openings 126 a, 126 b,126 c, 126 d in the unexpanded position, and hence also a minor axislength of each of the openings 126 a, 126 b, 126 c, 126 d. Although thesize identifiers 130 representing various sizes are shown asalphabetical characters printed, embossed, or otherwise viewable on thetemplate tool 120, a person skilled in the art will appreciate that thesize identifiers 130 can have any size, shape, and configuration, suchas any combination of colors or alphabetical, numerical, and symboliccharacters.

The template tool 120 can also optionally include size or ruler markings132 configured to identify the major axis lengths of the openings 126 a,126 b, 126 c, 126 d, e.g., the expanded length l_(b2). The rulermarkings 132 can have any size, shape, and configuration, such as about1 mm spaced tick marks as illustrated. Although the ruler markings 132are only shown on an elongate bar 134 of the first movable member 122located between the first and second openings 126 a, 126 b, a personskilled in the art will appreciate that any of the elongate bars 134separating any of the openings 126 a, 126 b, 126 c, 126 d, and/or anyother portion of the first and/or second movable members 122, 124, caninclude ruler markings. A longitudinal length of the bars 134 can definea maximum major axis length of each of the openings 126 a, 126 b, 126 c,126 d when the template tool 120 is in a fully expanded position, whichis illustrated in FIG. 23 .

In use, the template tool 120 can provide an oblong-shaped opening thatcan be used to create a desirably sized tissue scaffold. Fornon-limiting example, if the ovular shape in the tissue shown in FIG. 15having a minor axis length of double r7 has been created and cleared toform an ovular cavity in the tissue, a major axis length of the ovularshape can be measured, e.g., using the measuring device 112 of FIG. 21 .The first and second members of the template tool 120 can be moved suchthat the one of the openings 126 a, 126 b, 126 c, 126 d having a radiusequal to the radius r7 in the unexpanded position defines in theexpanded position an oblong opening having a major axis length equal tothe major axis length of the cavity formed at the defect site 80. Aprepared tissue scaffold 136 can be positioned under the template tool120, as illustrated in an exemplary embodiment in FIG. 24 , to at leastbe positioned under the desirably sized opening, in this embodimentunder the second opening 126 b. An area of the prepared tissue scaffold136 having a high concentration of deposited tissue can be positionedunder the second opening 126 b to help maximize an amount of tissueavailable in the implant to aid in tissue regeneration. A desirablysized scaffold can be cut in any way from the prepared tissue scaffold136 using the second opening 126 b as a template, as will be appreciatedby a person skilled in the art, such as by using a scribing instrumentto cut the scaffold 136 around a perimeter of the second opening 126 b,or marking the scaffold using the opening 126 b and cutting it afterremoving the template tool 120.

Optionally, the scaffold 136 can be positioned or sandwiched between thetemplate tool 120 and a second template tool similar to the templatetool 120 of FIG. 23 , which can help make preparing to cut and/orcutting the scaffold 136 an easier, faster process. The two templatetools can be independent from one another, or they can be attachedtogether, such as by having their first and second movable membersattached together with a space between the tools such that a scaffoldcan be positioned in the space. The template tools can be fixedly orremovably attached to one another, e.g., using alignment pins orientedperpendicular to planes of the tools. When attached, the movable membersof the tools can move together.

In another exemplary embodiment using a template tool to help properlysize a tissue replacement implant, the template tool can be in the formof a flexible, transparent film. Generally, the flexible, transparentfilm can be configured to be introduced into a body of a patientadjacent an implant-receiving tissue cavity to help size the cavity.Because the film is transparent, it can be positioned above the cavityto help visualize a size of the cavity through and relative to the film.The film can be removed from the patient's body, trimmed to a visualizedsize of the cavity, and used as a pattern to cut a tissue replacementscaffold to a desired size. A person skilled in the art will appreciatethat the term “transparent” as used herein is intended to include anycombination of one or more see-through materials, including opticallyclear material and translucent material. The film can be any one or morecolors, and in an exemplary embodiment, the film is formed of a materialin a contrast color such as blue or green that can be easily seen in abody of a patient. While any flexible material can be used to form thefilm, in an exemplary embodiment the material can be biocompatible andnon-malleable such that pressure applied to the film does notsubstantially deform the film, e.g., the film can substantially returnor “spring” to its original, planar configuration after being rolled orhaving pressure applied thereto as discussed further below. Onenon-limiting example of a biocompatible and non-malleable material isUltem™, available from SABIC Innovative Plastics of Pittsfield, Mass.The film can have any thickness configured to allow the film to beintroducible to and manipulable within a body of a patient, e.g., about0.005 inches. (about 0.127 mm).

As shown in one embodiment in FIG. 25 , a flexible, transparent film 140can include a planar sheet configured to have a least a portion thereofbe introduced into a body of a patient. The film 140 can include atleast one predefined shape 142, with each of the shapes 142 configuredto be removable from the sheet of film 140. The shapes 142 can beremovable from the film 140 in a variety of ways, as will be appreciatedby a person skilled in the art, such as by having scored perimeter edgesconfigured to allow the shapes 142 to be punched out of the film 140, asillustrated, or having perimeter outlines configured to serve as a guidefor a scribing instrument to cut out the shapes 142. When a shape 142 isremoved from the film 140, the shape 142 can maintain its planarconfiguration in a resting position. A person skilled in the art willappreciate that while the film 140 includes nine shapes 142, the film142 can include any number of shapes. A person skilled in the art willalso appreciate that each of the shapes 142 can have a same or differentgeometric form, e.g., circular, ovular, rectangular, triangular, etc.,as any one or more of the other shapes 142. Each of the shapes 142 caninclude a label 144 configured to identify a shape and/or size of itsassociated shape 142 to help determine which of the shapes 142 should bechosen to form a template for a given cavity formed in tissue. Althoughthe labels 144 are shown as alphabetical characters printed, embossed,or otherwise viewable on the film 140, a person skilled in the art willappreciate that the labels 144 can have any size, shape, andconfiguration, such as any combination of colors or alphabetical,numerical, and symbolic characters.

In an alternate embodiment illustrated in FIG. 25A, a flexible,transparent film 140′ can include a planar sheet having grid lines 141printed, embossed, or otherwise viewable on the film 140′ that can allowa shape to be cut from the film 140′ having a desired shape and size.The grid lines 141 can have uniform spacing, e.g., vertical andhorizontal lines about 1 mm apart as shown, similar to graph paper,configured to allow a shape having a particular size to be cut out ofthe film 140′. The grid lines 141 can also help in estimating a size ofa tissue cavity by providing at least one reference point to help invisualizing the cavity relative to the film 140′ and trimming the film140′ to a desired size, as discussed further below. The film 140′ can becut in any way, e.g., using a sharp edge of a scribing instrument, aswill be appreciated by a person skilled in the art. By allowing a shapeto be cut from the film 140′ freehand style, the film 140′ can provide agreater degree of size and shape choice.

Two or more flexible, transparent films, e.g., the film 140 and/or thefilm 140′, can be provided as part of a kit to help ensure that a filmshape is available that can closely match the size of a tissue cavitywithout requiring a large amount of film trimming, as discussed furtherbelow.

In use, as shown in one embodiment in FIG. 26 , a flexible, transparentfilm 142D can be introduced into a body of a patient to a site of acavity 148 formed in cartilage 146 in which a tissue scaffold will beimplanted. While the film 142D in this illustrated embodiment includesthe rectangular shape 142D removed from the film sheet 140 of FIG. 25 ,the film 142D can include any one of the shapes 142 punched from thefilm 140, a shape cut from the gridded film 140′, or any other flexible,transparent film. Additionally, while the illustrated cavity 148 iscircular-shaped, the film 142D can be used in connection with a cavityhaving any shape. In an exemplary embodiment the cavity 148 can beformed using a scribing tool as described above, although the film 142Dcan be used in connection with a cavity formed in any way known in theart or disclosed herein.

The film 142D can be introduced into the patient's body in any way, aswill be appreciated by a person skilled in the art. In one embodimentillustrated in FIGS. 26 and 27 , the film 142D can be held by a grasper150 and advanced through a passageway 152 p of an introducer device 152,or advanced directly through an opening in tissue, toward a site of thecavity 148. A person skilled in the art will appreciate that the term“grasper” as used herein is intended to encompass any surgicalinstrument that is configured to grab and/or attach to the film and/orother element and thereby manipulate the film and/or other element,e.g., forceps, retractors, movable jaws, magnets, adhesives, etc. Asdiscussed above, the film 142D can have a planar configuration, but itcan be moved to a folded configuration, as shown in FIG. 26 , fordelivery through the passageway 152 p. In this way, the film 142D can beadvanced through a passageway having a width w₁ that is less than oneof, and in an exemplary embodiment both of, the film shape's lengthl_(D) and width w_(D) (see FIG. 25 ), i.e., a maximum extent. A personskilled in the art will appreciate that the film 142D in the foldedconfiguration can be rolled to have a u-shaped cross-section as shown orcan be folded in any other way, e.g., rolled into a cylindrical shape,bent, compressed, etc.

When the film 142D is distally advanced beyond a distal end 152 a of thepassageway 152 p, the film 142D can move from the folded configurationback to its initial, planar configuration, as shown in FIG. 27 . As willbe appreciated by a person skilled in the art, the film 142D can movefrom the folded configuration to the planar configuration as the film142D advances distally beyond the passageway's distal end 152 a. Thefilm 142D can be formed from a material that causes the film 142D toautomatically move to the planar configuration from the foldedconfiguration, but at least one grasper can optionally be used to graspand help unfold the film 142D. With the film 142D advanced outside theintroducer device 152 and in the planar configuration, the film 152D canbe positioned over the cavity 148, as illustrated in FIG. 27 . With thefilm 152D being planar, looking through the film 142D to the cavity 148positioned underneath the film 142D, e.g., as viewed on a visualizationscreen outside the patient's body, can allow for a more accuratelyestimated size of the cavity 148 relative to the film 142D. A perimetershape of the cavity 148 with respect to the film 142D can be mentallyremembered, and/or the film 142D can be physically marked in any way, aswill be appreciated by a person skilled in the art, to help in cuttingthe film 142D to a size and shape substantially matching the size andshape of the cavity 148.

The film 142D can be trimmed from a size and shape in which it wasvisually compared with the cavity 148 so the size and shape of the film142D can more closely match the size and shape of the cavity 148. In anexemplary embodiment, the film 142D can be removed from the patient'sbody before trimming the film 142D. Trimming the film 142D outside thepatient's body to a visualized size and shape of the cavity 148 can helpprevent accidental injury to the cartilage 146 or other portion of thepatient, can provide for a larger working space, and can help improveaccuracy and visualization of cutting of the film 142D. The film 142Dcan, however, be trimmed to a desired size and shape to match the cavity148 inside and/or outside the patient's body. The film 142D can beremoved from the patient's body in any way, as will be appreciated by aperson skilled in the art, such as by being held by the grasper 150 andproximally pulled through the passageway 152 p of the introducer device152. The film 142D can be configured to move from the planar position tothe folded position as it is proximally drawn into the passageway 152 pin a similar way to how it can be configured to move from the foldedposition to the planar position, and a grasper can optionally help movethe film 142D from the planar configuration to the folded configuration.A person skilled in the art will appreciate that the film 142D can betrimmed in any way, e.g., using a cutting instrument 154 to cut a line156 in the film 142D, as illustrated in one embodiment shown in FIG. 28. The line 156 in this embodiment forms a circle so the film 142D can betrimmed to approximate the mentally remembered and/or physically markedsize and shape of the cavity 148.

In one embodiment illustrated in FIG. 29 , a trimmed portion 142D′ ofthe film 142D can be introduced into the body of the patient to comparethe trimmed film 142D′ with the cavity's size and shape. In an exemplaryembodiment, the trimmed film 142D′ can be introduced into the patient'sbody the same way that the film 142D was introduced using the introducerdevice 152 and the grasper 150, but a person skilled in the art willappreciate that the trimmed film 142D′ can be inserted in any way intothe patient's body, e.g., inserted directly through tissue using agrasper. The trimmed film 142D′ can be positioned over the cavity 148 todetermine if a size and shape of the trimmed film 142D′ substantiallymatches the cavity's size and shape. The cavity's and trimmed film'ssizes and shapes substantially match as illustrated in FIG. 29 , so thetrimmed film 142D′ can be removed from the body in any way and used as atemplate to cut a tissue scaffold for placement in the cavity 148. Ifthe cavity and trimmed film's sizes and shapes do not substantiallymatch, then the trimmed film 142D′ can, similar to that discussed above,be compared with the cavity 148 and re-trimmed inside and/or outside thebody. Such comparing and trimming can be repeated as many times asnecessary to create a film having a size and shape substantiallymatching the cavity's size and shape. If the film 142D is trimmed toomuch and is unacceptably smaller than a size and shape of the cavity148, the trimmed film 142D′ can be discarded and a new flexible,transparent film, e.g., another one of the shapes 142 on the film 140,can be used to begin another process of creating a film template.

Once the film 142D has been trimmed to a desired size and shape, if itwas trimmed at all, a prepared tissue scaffold 158 can be positionedunder the trimmed film 142D′, as illustrated in an exemplary embodimentin FIG. 30 . An area of the prepared tissue scaffold 158 having a highconcentration of deposited tissue can be positioned under the trimmedfilm 142D′ to help maximize an amount of tissue available in the implantto aid in tissue regeneration. A desirably sized scaffold can be cut inany way from the prepared tissue scaffold 158 using the trimmed film142D′ as a template, as will be appreciated by a person skilled in theart, such as by using a cutting instrument 160 to cut the scaffold 158around a perimeter of the trimmed film 142D′.

Regardless of how a tissue replacement implant is cut to a desired size,the implant can be delivered and affixed to the cavity formed in tissuein any way, as will be appreciated by a person skilled in the art.Non-limiting embodiments of methods and devices for delivering andaffixing a tissue replacement implant to tissue can be found in U.S.patent application Ser. No. 12/412,499 entitled “Methods And Devices ForDelivering And Affixing Tissue Scaffolds” filed on Mar. 27, 2009, whichis hereby incorporated by reference in its entirety.

The devices discussed herein can be made from any combination of rigidand/or flexible materials, but in an exemplary embodiment the materialsare biocompatible. A person skilled in the art will appreciate that theterms “flexible” and “rigid” as used herein are intended to encompass avariety of configurations. Generally, a “flexible” member has somedegree of elasticity, e.g., is capable of bending without breaking,while a “rigid” member lacks elasticity. In an exemplary embodiment, thedevices or at least portions thereof are composed of at least onebiocompatible and flexible material, e.g., plastic, titanium, stainlesssteel, etc.

A person skilled in the art will appreciate that the present inventionhas application in conventional endoscopic and open surgicalinstrumentation as well application in robotic-assisted surgery.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A surgical method, comprising: advancing an outershaft of a surgical device through a first tissue of a patient toposition a distal end of the shaft within the patient, the outer shaftbeing advanced through the first tissue with a longitudinal axis of theouter shaft angled relative to the first tissue, the outer shaft havinga passageway extending therethrough; with the distal end of the outershaft positioned within the patient, adjusting the outer shaft to changethe angle of the longitudinal axis of the outer shaft relative to thefirst tissue; with the distal end of the outer shaft positioned withinthe patient, advancing an inner shaft through the passageway of theouter shaft and engaging a second tissue of the patient with anextension extending distally from a body of the inner shaft, wherein theextension engages the second tissue without penetrating into a boneunderlying the second tissue; and with the distal end of the inner shaftengaging the second tissue of the patient, moving the outer shaftrelative to the inner shaft and thereby cutting the second tissue withthe outer shaft.
 2. The method of claim 1, wherein moving the outershaft includes rotating the outer shaft relative to the inner shaft. 3.The method of claim 1, wherein the second tissue has a defect therein,and the outer shaft cuts a shape in the second tissue enclosing thedefect.
 4. The method of claim 1, wherein the extension is advancedthrough the second tissue to contact the bone.
 5. The method of claim 1,wherein the longitudinal axis of the outer shaft is defined by aproximal elongate body of the outer shaft, and a distal arm of the outershaft is offset from the proximal elongate body at an angle relative tothe longitudinal axis of the outer shaft.
 6. The method of claim 5,wherein a longitudinal axis of the inner shaft advanced through theouter shaft is substantially aligned with the longitudinal axis of theouter shaft and is offset from a longitudinal axis of the distal arm. 7.The method of claim 1, wherein the outer shaft cuts a shape in thesecond tissue, and the method further comprises removing from thepatient the second tissue that is within the shape.
 8. The method ofclaim 1, wherein the extension is integrally formed with the body of theinner shaft.
 9. A surgical method comprising: advancing an outer shaftof a surgical device through a first tissue of a patient to position adistal end of the shaft within the patient, the outer shaft beingadvanced through the first tissue with a longitudinal axis of the outershaft angled relative to the first tissue, the outer shaft having apassageway extending therethrough; with the distal end of the outershaft positioned within the patient, adjusting the outer shaft to changethe angle of the longitudinal axis of the outer shaft relative to thefirst tissue; with the distal end of the outer shall positioned withinthe patient, advancing an inner shaft through the passageway of theouter shaft and engaging a second tissue the patient with an extensionextending distally from a body of the inner shaft; with the distal endthe inner shaft engaging the second tissue of the patient, moving theouter shaft relative to the inner shaft and thereby cutting the secondtissue with the outer shaft; and moving the extension from a firstposition, in which the extension is contained within the body of theinner shaft, to a second position, in which the extension extendsdistally beyond a distal end of the body of the inner shaft.
 10. Asurgical method, comprising: advancing an outer shaft of a surgicaldevice through a first tissue of a patient to position a distal end ofthe shaft within the patient, the outer shaft being advanced through thefirst tissue with a longitudinal axis of the outer shaft angled relativeto the first tissue, the outer shaft having a passageway extendingtherethrough; with the distal end of the outer shaft positioned withinthe patient, adjusting the outer shaft to change the angle of thelongitudinal axis of the outer shaft relative to the first tissue; withthe distal end of the outer shaft positioned within the patient,advancing an inner shaft through the passageway of the outer shaft suchthat a second tissue of the patient is engaged by the inner shaft,wherein a handle of the inner shaft limits a distance that the innershaft can move distally beyond a distal end of the outer shaft; and withthe inner shaft engaging the second tissue of the patient, moving theouter shaft relative to the inner shaft and thereby cutting the secondtissue with the outer shaft; wherein the outer shaft has a handle; thehandle of the inner shaft has a diameter larger than a diameter of thepassageway of the outer shaft; and the handle of the inner shaftabutting the handle of the outer shaft limits the distance that theinner shaft can move distally beyond the distal end of the outer shaft.11. The method of claim 10, wherein moving the outer shaft includesrotating the outer shaft relative to the inner shaft.
 12. The method ofclaim 10, wherein the second tissue has a defect therein, the outershaft cuts a shape in the second tissue enclosing the defect, and themethod further comprises removing from the patient the second tissuethat is within the shape.
 13. The method of claim 10, wherein the secondtissue overlies a bone, and the inner shaft is advanced through thesecond tissue to contact the bone.
 14. The method of claim 10, whereinthe longitudinal axis of the outer shaft is defined by a proximalelongate body of the outer shaft, and a distal arm of the outer shaft isoffset from the proximal elongate body at an angle relative to thelongitudinal axis of the outer shaft; and a longitudinal axis of theinner shaft advanced through the outer shaft is substantially alignedwith the longitudinal axis of the outer shaft and is offset from alongitudinal axis of the distal arm.
 15. A surgical method, comprising:advancing an outer shaft of a surgical device through a first tissue ofa patient to position a distal end of the shaft within the patient, theouter shaft being advanced through the first tissue with a longitudinalaxis of the outer shaft angled relative to the first tissue, the outershaft having a passageway extending therethrough; with the distal end ofthe outer shaft positioned within the patient, adjusting the outer shaftto change the angle of the longitudinal axis of the outer shaft relativeto the first tissue; with the distal end of the outer shaft positionedwithin the patient, advancing an inner shaft through the passageway ofthe outer shaft and contacting a second tissue of the patient with theinner shaft without the inner shaft penetrating into a bone underlyingthe second tissue; and with the inner shaft contacting the second tissueof the patient without the inner shaft penetrating into the bone, movingthe outer shaft relative to the inner shaft and thereby cutting thesecond tissue with the outer shaft.
 16. The method of claim 15, whereinmoving the outer shaft includes rotating the outer shaft relative to theinner shaft to cut a shape in the second tissue enclosing a defect inthe second tissue; and the method further comprises, after cutting theshape, removing from the patient the second tissue that is within theshape.
 17. The method of claim 15, wherein the longitudinal axis of theouter shaft is defined by a proximal elongate body of the outer shaft,and a distal arm of the outer shaft is offset from the proximal elongatebody at an angle relative to the longitudinal axis of the outer shaft;and a longitudinal axis of the inner shaft advanced through the outershaft is substantially aligned with the longitudinal axis of the outershaft and is offset from a longitudinal axis of the distal arm.
 18. Themethod of claim 15, wherein a handle of the inner shaft limits adistance that the inner shaft can move distally beyond a distal end ofthe outer shaft.